P
US7312190B2ExpiredUtilityPatentIndex 92

Pharmaceutical compositions of apolipoprotein A-I agonists and their use to treat dyslipidemic disorders

Assignee: DASSEUX JEAN-LOUISPriority: Sep 29, 1997Filed: Mar 15, 2004Granted: Dec 25, 2007
Est. expirySep 29, 2017(expired)· nominal 20-yr term from priority
Inventors:DASSEUX JEAN-LOUISSEKUL RENATEBUETTNER KLAUSCORNUT ISABELLEMETZ GUENTHERDUFOURCQ JEAN
A61P 9/02A61P 3/06A61P 9/10C07K 14/775C07K 7/08A61K 38/1709A61P 3/04A61K 38/00
92
PatentIndex Score
13
Cited by
137
References
11
Claims

Abstract

The present invention provides peptides and peptide analogues that mimic the structural and pharmacological properties of human ApoA-I. The peptides and peptide analogues are useful to treat a variety of disorders associated with dyslipidemia.

Claims

exact text as granted — not AI-modified
1. The pharmaceutical composition comprising an ApoA-I agonist and a pharmaceutically acceptable carrier, excipient or diluent; wherein the ApoA-I agonist is in the form of an ApoA-I agonist-lipid complex, said complex comprising the ApoA-I agonist and a lipid;
 wherein the ApoA-I agonist comprises: 
 a 22 to 29-residue peptide or peptide analogue which forms an amphipathic α-helix in the presence of lipids and which comprises formula (I):
   Z 1 -X 1 -X 2 -X 3 -X 4 -X 5 -X 6 -X 7 -X 8 -X 9 -X 10 -X 11 -X 12 -X 13 -X 14 -X 15 -X 16 -X 17 -X 18 -X 19 X 20 -X 21 -X 22 X 23 Z 2   
 
 or a pharmaceutically acceptable salt thereof, wherein:
 X 1  is Pro (P), Ala (A), Gly (G), Gln (Q), Asn (N), Asp (D) or D-Pro (p); 
 X 2  is an aliphatic residue; 
 X 3  is Leu (L) or Phe (F); 
 X 4  is an acidic residue; 
 X 5  is Leu (L) or Phe (F); 
 X 6  is Leu (L) or Phe (F); 
 X 7  is a hydrophilic residue; 
 X 8  is an acidic or a basic residue; 
 X 9  is Leu (L) or Gly (G); 
 X 10  is Leu (L), Trp (W) or Gly (G); 
 X 11  is a hydrophilic residue; 
 X 12  is a hydrophilic residue; 
 X 13  is Gly (G) or an aliphatic residue; 
 X 14  is Leu (L), Trp (W), Gly (G) or Nal; 
 X 15  is is a hydrophilic residue; 
 X 16  is a hydrophobic residue; 
 X 17  is a hydrophobic residue; 
 X 18  is Gln (Q), Asn (N) or a basic residue; 
 X 19  is Gln (Q), Asn (N) or a basic residue; 
 X 20  is a basic residue; 
 X 21  is an aliphatic residue; 
 X 22  is a basic residue; 
 X 23  is absent or a basic residue; 
 Z 1  is H 2 N— or RC(O)NR′—; 
 Z 2  is —C(O)NRR, —C(O)OR or —C(O)OH or a salt thereof; 
 each R is independently —H, (C 1 -C 6 )alkyl, (C 1 -C 6 )alkenyl, (C 1 -C 6 )alkynyl, (C 5 -C 20 )aryl, (C 6 -C 26 )alkaryl, 5-20 membered heteroaryl, 6-26 membered alkheteroaryl or a 1 to 7-residue peptide or peptide analogue in which one or more bonds between residues 1-7 are independently a substituted amide, an isostere of an amide or an amide mimetic; 
 each R′ is independently —H, (C 1 -C 6 )alkyl, (C 1 -C 6 )alkenyl, (C 1 -C 6 )alkynyl, (C 5 -C 20 )aryl, (C 6 -C 26 )alkaryl, 5-20 membered heteroaryl or 6-26 membered alkheteroaryl; and 
 each “-” between residues X 1  through X 23  independently designates an amide linkage, a substituted amide linkage, an isostere of an amide or an amide mimetic; or 
 
 a N-terminally blocked form, a C-terminally blocked form, or an N- and C-terminally blocked form of formula (I). 
 
     
     
       2. The pharmaceutical composition of  claim 1  wherein X 7  of the ApoA-I agonist is a basic residue. 
     
     
       3. The pharmaceutical composition of  claim 1  wherein X 3 , X 6 , X 9  and X 10  of the ApoA-I agonist are hydrophobic residues. 
     
     
       4. The pharmaceutical composition of  claim 1  wherein the ApoA-I agonist is a 22-23 residue peptide or peptide analogue according to formula (I). 
     
     
       5. The pharmaceutical composition of  claim 4  wherein:
 the “-” between residues X 1  through X 23  designates —C(O)NH—; 
 Z 1  is H 2 N—; and 
 Z 2  is —C(O)OH or a salt thereof. 
 
     
     
       6. The ApoA-I agonist of  claim 5 , in which:
 X 1  is Pro (P), Ala (A), Gly (G), Asn (N), Gln (Q), Asp (D) or D-Pro (p); 
 X 2  is Ala (A), Val (V) or Leu (L); 
 X 3  is Leu (L) or Phe (F); 
 X 4  is Asp (D) or Glu (E); 
 X 5  is Leu (L) or Phe (F); 
 X 6  is Leu (L) or Phe (F); 
 X 7  is Lys (K), Arg (R) or Orn; 
 X 8  is Asp (D) or Glu (E); 
 X 9  is Leu (L) or Gly (G); 
 X 10  is Leu (L), Trp (W) or Gly (G); 
 X 11  is Asn (N) or Gln (Q); 
 X 12  is Glu (E) or Asp (D); 
 X 13  is Gly (G), Leu (L) or Aib; 
 X 14  is Leu (L), Nal, Trp (W) or Gly (G); 
 X 15  is Asp (D) or Glu (E); 
 X 16  is Ala (A), Nal, Trp (W), Leu (L), Phe (F) or Gly (G); 
 X 17  is Gly (G), Leu (L) or Nal; 
 X 18  is Gln (Q), Asn (N), Lys (K) or Orn; 
 X 19  is Gln (Q), Asn (N), Lys (K) or Orn; 
 X 20  is Lys (K) or Orn; 
 X 21  is Leu (L); 
 X 22  is Lys (K) or Orn; and X 23  is absent or Lys (K). 
 
     
     
       7. The pharmaceutical composition of  claim 6  wherein X 23  of the ApoA-I agonist is absent. 
     
     
       8. The pharmaceutical composition of  claim 1  wherein one of X 18  or X 19  is Gln (Q) or Asn (N) and the other of X 18  or X 19  is Lys (K) or Orn. 
     
     
       9. The pharmaceutical composition of  claim 1  wherein the peptide or peptide analog is selected from the group consisting of: 
       
         
           
                 
                 
                 
                 
               
                   peptide 1 
                   PVLDLFRELLNELLEZLKQKLK 
                   (SEQ ID NO:1) 
                     
                 
                     
                 
                   peptide 2 
                   GVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:2) 
                 
                     
                   K 
                 
                     
                 
                   peptide 3 
                   PVLDLFRELLNELLEWLKQKLK 
                   (SEQ ID NO:3) 
                 
                     
                 
                   peptide 4 
                   PVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:4) 
                 
                     
                 
                   peptide 5 
                   pVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:5) 
                 
                     
                   K 
                 
                     
                 
                   peptide 6 
                   PVLDLFRELLNEXLEALKQKLK 
                   (SEQ ID NO:6) 
                 
                     
                 
                   peptide 7 
                   PVLDLFKELLNELLEALKQKLK 
                   (SEQ ID NO:7) 
                 
                     
                 
                   peptide 8 
                   PVLDLFRELLNEGLEALKQKLK 
                   (SEQ ID NO:8) 
                 
                     
                 
                   peptide 9 
                   PVLDLFRELGNELLEALKQKLK 
                   (SEQ ID NO:9) 
                 
                     
                 
                   peptide 10 
                   PVLDLFRELLNELLEAZKQKLK 
                   (SEQ ID NQ:10) 
                 
                     
                 
                   peptide 11 
                   PVLDLFKELLQELLEALKQKLK 
                   (SEQ ID NO:11) 
                 
                     
                 
                   peptide 12 
                   PVLDLFRELLNELLEAGKQKLK 
                   (SEQ ID NO:12) 
                 
                     
                 
                   peptide 13 
                   GVLDLFRELLNEGLEALKQKLK 
                   (SEQ ID NO:13) 
                 
                     
                 
                   peptide 14 
                   PVLDLFRELLNELLEALOQOLO 
                   (SEQ ID NO:14) 
                 
                     
                 
                   peptide 15 
                   PVLDLFRELWNELLEALKQKLK 
                   (SEQ ID NO:15) 
                 
                     
                 
                   peptide 16 
                   PVLDLLRELLNELLEALKQKLK 
                   (SEQ ID NO:16) 
                 
                     
                 
                   peptide 17 
                   PVLELFKELLQELLEALKQKLK 
                   (SEQ ID NO:17) 
                 
                     
                 
                   peptide 18 
                   GVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:18) 
                 
                     
                 
                   peptide 19 
                   pVLDLFRELLNEGLEALKQKLK 
                   (SEQ ID NO:19) 
                 
                     
                 
                   peptide 20 
                   PVLDLFREGLNELLEALKQKLK 
                   (SEQ ID NO:20) 
                 
                     
                 
                   peptide 21 
                   pVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:21) 
                 
                     
                 
                   peptide 22 
                   PVLDLFRELLNELLEGLKQKLK 
                   (SEQ ID NO:22) 
                 
                     
                 
                   peptide 23 
                   PLLELFKELLQELLEALKQKLK 
                   (SEQ ID NO:23) 
                 
                     
                 
                   peptide 24 
                   PVLDLFRELLNELLEALQKKLK 
                   (SEQ ID NO:24) 
                 
                     
                 
                   peptide 25 
                   PVLDFFRELLNEXLEALKQKLK 
                   (SEQ ID NO:25) 
                 
                     
                 
                   peptide 26 
                   PVLDLFRELLNELLELLKQKLK 
                   (SEQ ID NO:26) 
                 
                     
                 
                   peptide 27 
                   PVLDLFRELLNELZEALKQKLK 
                   (SEQ ID NO:27) 
                 
                     
                 
                   peptide 28 
                   PVLDLFRELLNELWEALKQKLK 
                   (SEQ ID NO:28) 
                 
                     
                 
                   peptide 29 
                   AVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:29) 
                 
                     
                 
                   peptide 123 
                   QVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:123) 
                 
                     
                 
                   peptide 124 
                   PVLDLFOELLNELLEALOQOLO 
                   (SEQ ID NO:124) 
                 
                     
                 
                   peptide 125 
                   NVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:125) 
                 
                     
                 
                   peptide 126 
                   PVLDLFRELLNELGEALKQKLK 
                   (SEQ ID NO:126) 
                 
                     
                 
                   peptide 127 
                   PVLDLFRELLNELLELLKQKLK 
                   (SEQ ID NO:127) 
                 
                     
                 
                   peptide 128 
                   PVLDLFRELLNELLEFLKQKLK 
                   (SEQ ID NO:128) 
                 
                     
                 
                   peptide 129 
                   PVLELFNDLLRELLEALQKKLK 
                   (SEQ ID NO:129) 
                 
                     
                 
                   peptide 130 
                   PVLELFNDLLRELLEALKQKLK 
                   (SEQ ID NO:130) 
                 
                     
                 
                   peptide 131 
                   PVLELFKELLNELLDALRQKLK 
                   (SEQ ID NO:131) 
                 
                     
                 
                   peptide 132 
                   PVLDLFRELLENLLEALQKKLK 
                   (SEQ ID NO:132) 
                 
                     
                 
                   peptide 133 
                   PVLELFERLLEDLLQALNKKLK 
                   (SEQ ID NO:133) 
                 
                     
                 
                   peptide 134 
                   PVLELFERLLEDLLKALNQKLK 
                   (SEQ ID NO:134) 
                 
                     
                 
                   peptide 135 
                   DVLDLFRELLNELLEALKQKLK 
                   (SEQ ID NO:135) 
                 
                     
                 
                   peptide 136 
                   PALELFKDLLQELLEALKQKLK 
                   (SEQ ID NO:136) 
                 
                     
                 
                   peptide 137 
                   PVLDLFRELLNEGLEAZKQKLK 
                   (SEQ ID NO:137) 
                 
                     
                 
                   peptide 138 
                   PVLDLFRELLNEGLEWLKQKLK 
                   (SEQ ID NO:138) 
                 
                     
                 
                   peptide 139 
                   PVLDLFRELWNEGLEALKQKLK 
                   (SEQ ID NO:139) 
                 
                     
                 
                   peptide 140 
                   PVLDLFRELLNEGLEALOQOLO 
                   (SEQ ID NO:140) 
                 
                     
                 
                   peptide 141 
                   PVLDFFRELLNEGLEALKQKLK 
                   (SEQ ID NO:141) 
                 
                     
                 
                   peptide 142 
                   PVLELFRELLNEGLEALKQKLK 
                   (SEQ ID NO:142) 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
         and the N-terminal acylated and/or C-terminal amidated or esterified forms thereof, wherein X is Aib; Z is Nal; and O is Orn. 
       
     
     
       10. The pharmaceutical composition of  claim 9  wherein the peptide or peptide analog is SEQ ID NO:4. 
     
     
       11. The pharmaceutical composition of  claim 1  wherein X 3  is Leu (L) or Phe (F), X 6  is Phe (F), X 9  is Leu (L) or Gly (G), and X 10  is Leu (L), Trp (W) or Gly (G).

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